BS 6256-2021 Packaging for terminally-sterilized medical devices – Method for determination of methylene blue particulate penetration

BS 6256-2021 Packaging for terminally-sterilized medical devices – Method for determination of methylene blue particulate penetration.
5.6 Aatu,, wctSon pump
5.7 Air drier.
6 Procedure
6.1 Prelliniraary
6.1.1 FIll the altwnlzer with a 1% methylene blue sohitlon up tos level 6mm below that of the spray orlfice .appeo,unutely 500 ml of solution are required.
6.1.2 After a inasimum of 8 Ii operation. discard the .wdiylcne blur wlution and rrplilr with a fresh 1% solution of mdhylr.1r blue,
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6.2 Start.up instructions
6.2.1 Start up the apparatus as follows.
a) Turn die control cock (C) to OFF
b) Swetde on the suttioll p.amp
c) Close and ciasnp the unloaded test piece holder (T).
d) Clamp die unloaded test paper holder (F) firmly dosed.
e) Turn the control cock (C) to TRST
1) Adjust the air valve (V,) tn glue a flow of 30 dm’fmin through the bypass circuit.
g) Turn the control cock (C) to OFF
h) Adlusi control valve (1.!) to gwe a flow of 30 dm’/min through the test drcwit.
i) Turn on the conre,.sed air to the aomeaer and adlu;t the needle value (V) until the pressure gauge (D) registers 205 kPa 11w ball an the compressed aIr flownierer CM1) theelId now rise
to the calibranon math. If tie. air flow is Insufieclent. turn oil the cntnpresaed air seed dear the atoeniser )eta.
0Th I Steps 4 Ce, 5) aneSiedi the nwe,eeeal air oalv, wtlVn9, Co 5fl’, the rwe1swi.dflow nets, iS n.bseqsernt .prvSroees Wino, odpntmrots aptly fete, Show wetnqs meter mode.
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6.22 Man theairprn.saareatacoasantofzO5kPameairpressureasnottobe&ncreantdrobringthe air ile,w up to the correct value.
6.3 Preparation of standard stains
Prepare the standard stains as follows.
a) Close and clamp the unloaded test piece holder.
h) Clamp a short piece of biter paper he the test paper holder
c) Turn the control cock (C) toTlST he 20i During this perked check, and adlust if necessary, the air valve (Vi) in the test circuit to give a flow rate of 30 dm1fmln.BS 6256 pdf download.